Data Support Liso-cel as an ‘Important’ Therapy in Relapsed/Refractory CLL

Efficacy and safety data from the phase 1/2 TRANSCEND CLL 004 study (NCT03331198) presented during the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition appear tosupport lisocabtagene maraleucel (liso-cel; Breyanzi) as a next-line therapy for patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to Tatyana Feldman, MD, in an interview with CancerNetwork^®.¹

Feldman, an attending physician at John Theurer Cancer Center at Hackensack Meridian Health, highlighted data related to responses and survival in both the overall study population (n = 88) and a primary efficacy analysis set including those with disease progression following prior therapy with Bruton tyrosine kinase (BTK) inhibitors and venetoclax (Venclexta; n = 50). Based on these findings, she anticipates that liso-cel will hopefully receive regulatory approval as a treatment option in CLL.

The FDA previously granted priority review to liso-cel as a treatment for relapsed/refractory CLL or small lymphocytic lymphoma in November 2023 based on findings from the TRANSCEND CLL 004 study.²

Transcript:

We have an overall response rate [in the overall population] which sits at [48%] with a complete response rate—which was a primary end point—at [19%]. And what’s very important is that undetectable MRD in the blood for both cohorts was [66%], which is a very high number. As this analysis showed, that translates into duration of response; [these are] very meaningful responses. The duration of complete response is not reached, and duration of partial response is also quite long. We have 24.0 months for the total cohort and [12.4] months for the double-resistant cohort. Time to next therapy, which was a post-hoc analysis, was [18.4] months and [12.4] months, respectively.

These are very reputable numbers for these patient populations.

Overall survival was not reached in patients who achieved a response and [10.7] months for non-responders. From a standpoint of toxicity, there are no novel signals. Cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS] incidences were 85% and 45%, respectively. However, most of it was grade 1/2 and easily manageable. [Liso-cel] is hopefully going to be approved intervention soon [for] our armamentarium for [patients with] CLL.

This analysis is confirming the duration of the response [of liso-cel]. We have such a long duration of complete responses—which was not reached—as well as a very reputable duration of partial response of [18.4] months. This is a very important [treatment] that should be adopted by the community as a next-line therapy. That’s my opinion, particularly for the patients who progress after BTK inhibitors and BCL2 inhibitors.

References

1. Siddiqi T, Maloney DG, Kenderian SS, et al. Lisocabtagene maraleucel (liso-cel) in R/R CLL/SLL: 24-month median follow-up of TRANSCEND CLL 004. Blood. 2023;142(suppl 1):abstract 330. doi:10.1182/blood-2023-179529
2. U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). News release. Bristol Myers Squibb. November 9, 2023. Accessed December 14, 2023. https://shorturl.at/pJMS6